Additional information: the white hub connector disconnected from the catheter a few days after placement.Preliminary investigation results: a preliminary review of the manufacturing instructions, quality control, instructions for us, and trends was conducted during the investigation.No issues were found related to the reported complaint.The complaint device was not returned; therefore no physical examination could be performed.The lot number of the device is not known; accordingly a review of the device history record and complaint history of the lot could not be conducted.The manufacturing process for the proximal assembly is validated for both tensile strength and leakage.This case is currently under investigation.A final report will be send upon conclusion.
|